Identity
- Trade Name
- PowerLook PRO Tomo Detection FRU FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. FDA UDI
- Model / Reference
- V1.1 FDA UDI
- Description
- The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. FDA UDI
Identifiers
- Catalog Number
- D4D0181 FDA UDI
- Primary DI / UDI-DI
- 00858012005267 FDA UDI
- PMA Number
- P160009 FDA UDI
- FDA Product Code
- MYN FDA UDI
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic diagnostic x-ray system application software
PowerLook PRO Tomo Detection FRU by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P160009 also covers:
- PowerLook PRO Tomo Detection and SLD, GE — Icad, Inc.
- PowerLook PRO Tomo Detection and SLD, GE — Icad, Inc.
- PowerLook PRO Tomo Detection and SLD, GE — Icad, Inc.
- PowerLook PRO with Tomo Detection — Icad, Inc.
- PowerLook PRO with Tomo Detection, Upgrade, GE — Icad, Inc.
- PowerLook Tomo Detection Software — Icad, Inc.
- PowerLook Tomo Detection and SecondLook Digital License — Icad, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA UDI 6330e104-b30f-4f75-a488-b4a48c4b964d 36 fields · synced May 30, 2026